BEUDAMED
    FDA Recall Terminated

    Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881850558

    Recall: Z-1250-2021 · Initiated February 9, 2021

    Recall

    Recall Number
    Z-1250-2021
    Event Number
    87313
    Firm
    Cardinal Health
    FEI Number
    3014524790
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    February 9, 2021
    Terminated
    April 9, 2024
    Address
    200 LLC 15 Hampshire St, Bldg 5, Mansfield, MA, 02048-1113

    Description

    Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881850558

    Reason

    Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens

    Action

    Cardinal Health issued Urgent Medical Device Recall letter on 2/9/21via overnight mail. Letter states reason for recall, health risk and action to take: 1. INSPECT your inventory for the affected product code and lot number (see Attachment A for examples). 2. SEGREGATE and QUARANTINE all on-hand affected product. 3. PLEASE RETURN the enclosed acknowledgment form via facsimile (614-652-9648) or email ([email protected]) and indicate the product code, lot and quantity of product youve quarantined. Please respond regardless of whether or not you have affected product. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5:00pm EST: Hospital800-964-5227 Federal Government800-444-1166 Distributor800-635-6021 All other customers888-444-54401. 6. Customers that did not receive product directly from Cardinal Health should return product through the location where they purchased it. Contact Cardinal Health at 800-292-9332.

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of AE, Japan.

    Quantity

    243,250 units